Tech Talk: Israeli firm wins landmark FDA clearance for injection-based diabetes app
3 Articles
3 Articles
Tech Talk: Israeli firm wins landmark FDA clearance for injection-based diabetes app
Petah Tikva-based DreaMed Diabetes has just received FDA 510(k) clearance for MODI, a prescription medical application that automatically optimizes insulin dosing for adults with type 2 diabetes.
FDA Clears DreaMed MODI: First CGM-Driven Insulin Dose Optimization App for Type 2 Injection Therapy
What You Should Know The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to MODI, a prescription software-as-a-medical-device (SaMD) application developed by DreaMed Diabetes Ltd. that calculates and delivers autonomous insulin dose titration recommendations directly to patients. The clearance establishes a new digital therapeutics category by bringing automated algorithmic dose optimization to the ...
AJN Agency.- The Israeli startup DreaMed Diabetes received approval from the U.S. Food and Drug Administration (FDA) for MODI, an application that analyzes glucose levels and insulin treatment data to offer customized dose adjustment recommendations directly on the patient's mobile phone. [...] The Entry An Israeli insulin dose adjustment application receives approval from U.S. drug administration aparece primero en AJN Agencia de Noticias.
Coverage Details
Bias Distribution
- 100% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
